Cefpodoxime

Overview

Cefpodoxime is an oral third generation cephalosporin antibiotic with effectiveness against most Gram positive and Gram negative bacteria. Commonly used to treat acute otitis media, pharyngitis, and sinusitis, cefpodoxime proxetil is a prodrug which is absorbed and de-esterified by the intestinal mucosa to Cefpodoxime.

Indication

Indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms.

Associated Conditions

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
Acute Otitis Media (AOM)
Acute Sinusitis
Acute Tracheobronchitis
Acute maxillary sinusitis
Bacterial Infections
Bacterial Pneumonia
Community Acquired Pneumonia (CAP)
Lower Respiratory Tract Infection (LRTI)
Neisseria Gonorrhoeae Infection
Otitis Media (OM)
Pharyngitis
Skin and Soft Tissue Infections (SSTIs)
Streptococcal Pharyngitis
Superinfection bacterial
Tonsillitis
Tonsillitis streptococcal
Uncomplicated Urinary Tract Infections
Upper Respiratory Tract Infection
Uncomplicated Lower Respiratory Tract Infection (LRTI)
Uncomplicated Upper Respiratory Tract Infection
Uncomplicated Urethritis gonococcal
Uncomplicated skin and subcutaneous tissue bacterial infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants	2018/04/09	NCT03491748	Phase 1	Completed	Entasis Therapeutics
Healthy Patients & Effect of Antibiotics	2017/03/31	NCT03098485	Not Applicable	Completed	Washington University School of Medicine
Cefpodoxime vs Ciprofloxacin for Acute Cystitis	2005/09/19	NCT00194532	Not Applicable	Completed	University of Washington

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	65862-095	ORAL	100 mg in 1 1	1/3/2024
Cefpodoxime Proxetil	Amici Pharmaceuticals, LLC.	69292-516	ORAL	200 mg in 1 1	1/3/2023
Cefpodoxime Proxetil	Sandoz Inc	0781-5438	ORAL	100 mg in 1 1	7/28/2014
Cefpodoxime Proxetil	Sandoz Inc	0781-5439	ORAL	200 mg in 1 1	7/28/2014
Cefpodoxime Proxetil	NorthStar Rx LLC	16714-402	ORAL	50 mg in 5 mL	1/4/2024
CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	65862-096	ORAL	200 mg in 1 1	1/3/2024
Cefpodoxime Proxetil	Ascend Laboratories, LLC	67877-878	ORAL	100 mg in 1 1	4/14/2023
CEFPODOXIME PROXETIL	Cronus Pharma LLC	69043-007	ORAL	200 mg in 1 1	1/4/2024
Cefpodoxime Proxetil	NorthStar Rx LLC	16714-403	ORAL	100 mg in 5 mL	1/4/2024
CEFPODOXIME PROXETIL	NorthStar Rx LLC	16714-394	ORAL	100 mg in 1 1	1/3/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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